Tracleer and PPH News Medtronic Announces Expanded Labeling for Its Model 407C General Medication Pump NORTHRIDGE, Calif.--(BUSINESS WIRE)--April 19, 2005--
Expanded Labeling Increases Therapy Applications; Allows Medication Delivery Using Subcutaneous, Intravenous and Intrathecal (spinal) Infusion The diabetes business unit of Medtronic, Inc. (NYSE:MDT) today announced U.S. Food and Drug Administration (FDA) clearance of expanded labeling for its external model 407C general medication infusion pump. In addition to subcutaneous delivery, the infusion pump is now cleared to deliver medications labeled for intravenous and intrathecal (spinal) infusion. Similar to Medtronic's external insulin pumps used to treat diabetes, the Model 407C general medication pump is a pager-size device that delivers precise doses of medication to a patient's body. "Medtronic's proven skill in delivering difficult-to-administer drugs is particularly well-suited for biotech proteins and peptides that cannot be taken orally," said Robert Guezuraga, president of Medtronic Diabetes. "The expanded labeling allows us to explore new therapy opportunities to help more patients who struggle with severe chronic medical conditions." The external pump can deliver medications to treat a variety of medical conditions including, but not limited to, cancer and pain. Currently, Medtronic's general medication pump is being used to deliver Remodulin(R), manufactured by United Therapeutics Corporation (NASDAQ:UTHR), for the treatment of pulmonary arterial hypertension. The new labeling allows Remodulin to be administered to patients intravenously, in addition to subcutaneous delivery. "We are delighted to offer a new therapy option to patients who struggle with pulmonary arterial hypertension, an extremely devastating disease that constricts the arteries serving the lungs, slowly causing heart failure," said Martine Rothblatt, Ph.D., chairman and chief executive officer of United Therapeutics. "Since there is no known cure, this is an important milestone for up to 50,000 Americans who suffer from this difficult disease." Medtronic MiniMed (www.minimed.com) is the world leader in pump therapy and continuous glucose monitoring. The company's products include external insulin pumps, related disposable products, and a continuous glucose monitoring system. Medtronic, Inc. (www.medtronic.com), headquartered in Minneapolis, is the world's leading medical technology company, providing lifelong solutions for people with chronic disease. United Therapeutics is a biotechnology company focused on the development and commercialization of unique products for patients with chronic and life-threatening cardiovascular, cancer and infectious diseases. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's Annual Report on Form 10-K for the year ended April 30, 2004. Actual results may differ materially from anticipated results. Remodulin is an FDA approved drug as a continuous subcutaneous infusion or intravenous infusion (for those not able to tolerate a subcutaneous infusion) for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms to diminish symptoms associated with exercise. In clinical trials, the most common side effects reported with subcutaneous Remodulin therapy included infusion site pain (85%) and infusion site reaction (83%). Other adverse events included headache (27%), diarrhea (25%), nausea (22%), rash (14%), jaw pain (13%), vasodilatation (11%), dizziness (9%), edema (9%), pruritus (8%) and hypotension (4%). Among patients (n=38) treated for twelve weeks with intravenous Remodulin in an open-label study, two patients experienced either line infections or sepsis. Other events potentially related to intravenous dosing of Remodulin include arm swelling, paresthesias, hematoma and pain. Remodulin is a potent pulmonary and systemic vasodilator and should be used only by clinicians experienced in the diagnosis and treatment of pulmonary arterial hypertension. Remodulin should be used with caution in patients with hepatic or renal impairment. Remodulin has not been studied in conjunction with Flolan(R) or Tracleer(R).
Contacts
Medtronic, Inc.
Investor Relations:
Rob Carson, 763-505-2705
or
Public Relations:
Deanne McLaughlin, 818-576-4325
At A Glance Medtronic, Inc.
Headquarters: Minneapolis, Minnesota
Website: http://www.medtronic.com
CEO: Art Collins
Employees: 32,000
Ticker: MDT (NYSE)
Revenues: $9.087 billion for FY04 (2004)
Net Income: $1.959 billion for FY04 (2004)
Source: via Business Wire
Updated 04/11/2005 by company
Encysive delays TBC3711 studies
By Staff Writer
24th March 2006 - Encysive Pharmaceuticals has been forced to place its hypertension treatment candidate TBC3711 on clinical hold after making an "unusual finding" following dosing with intravenous TBC3711 in a single rat that had displayed abnormalities at baseline.
The delay follows a standard 30-day review process associated with the investigational new drug (IND) application for the intravenous form of TBC3711, Encysive Pharmaceuticals' next-generation selective endothelin receptor antagonist.
The FDA believes, and Encysive has agreed, that it requires further review before proceeding with patient dosing. All clinical testing with TBC3711, including oral and intravenous formulations, will be suspended.
Encysive said that the company will work with the FDA to resolve this issue as quickly as possible. Meanwhile, the biopharmaceutical firm's stock has fallen by around 5% following the announcement.
TBC3711 has demonstrated encouraging kinetics in phase I studies and, based on the positive data for the company's first endothelin A antagonist, sitaxsentan, TBC3711 is expected to hold promise as a next-generation compound. It will, therefore, be interesting to see what consequences this trial delay may have
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